| CTRI Number |
CTRI/2022/10/046610 [Registered on: 19/10/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of ketamine and dexmedetomidine versus ketamine and fentanyl for intravenous sedation in children undergoing infraumbilical surgeries under spinal anaesthesia |
|
Scientific Title of Study
|
A comparative study of ketamine and dexmedetomidine versus ketamine and fentanyl for intravenous sedation in children undergoing infraumbilical surgeries under spinal anaesthesia |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syeda Maryam Quadri |
| Designation |
Junior resident department of anesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Junior resident, department of anesthesiology, Vijayanagar institute of medical sciences, cantonment,Department of anesthesiology Vijayanagar institute of medical sciences, cantonment Ballari
Vijayanagar Institute of medical sciences, new ot complex ballari
583104
India
Bellary
KARNATAKA
583104
India |
| Phone |
8971100393 |
| Fax |
|
| Email |
maryamquadri23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syeda Maryam quadri |
| Designation |
Junior resident department of Anaesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Junior resident, department of Anaesthesiology, vijayanagar Institute of medical sciences, cantonment, department of Anaesthesiology
new ot complex,vijayanagar Institute of medical sciences, ballari, karnataka
Bellary
KARNATAKA
583104
India |
| Phone |
9980600724 |
| Fax |
|
| Email |
maryamquadri23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BALA SUBRAMANYA H |
| Designation |
Professor in department of anesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Department of anesthesiology Vijayanagar institute of medical sciences, cantonment Ballari
New ot complex, vijayanagar Institute of medical sciences, ballari
583104
India
Bellary
KARNATAKA
583104
India |
| Phone |
9980600724 |
| Fax |
|
| Email |
halsanadu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesioloy and critical care,Vijayanagar Institute of Medical Sciences Bellary |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences |
| Address |
Vijayanagar institute of medical sciences, cantonment, Ballari pin code 583104 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Syeda Maryam Quadri |
Vijayanagar institute of medical sciences |
Vijayanagar institute of medical sciences, new ot complex, pediatric ot no
9,department of Anaesthesiology,Ballari pin code 583104
Bellary
KARNATAKA |
8971100393
maryamquadri23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vims ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj ketamine |
To compare quality of sedation by using modified observers assessment alertness/sedation scale by using ketamine as sedative 0.5mg/kg when child feels discomfort during surgery |
| Intervention |
Intra operative IV sedation using ketamine in combination with 2 different drugs(Dexmiditomedine and Fentanyl)in children undergoing infra umbilical surgeries under spinal anaesthesia |
To compare quality of sedation by using modified observers assessment alertness/sedation scale by using dexmedetomidine 0.5 microgram/ kg Or fentanyl 2microgram per kg as premedication and using ketamine as sedative 0.5mg/kg when child feels discomfort during surgery |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
All ASA physical status 1 and 2,belonging to 2-8yr age group of either sex posted for elective infraumbilical sugeries |
|
| ExclusionCriteria |
| Details |
(a)Parent’s refusal for the study
(b)Children with any contraindication for spinal anaesthesia
(c)Significant cardiovascular, respiratory, CNS, renal system and endocrinal disorders
(d)Allergy to the study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare quality of sedation by using Modified Observer’s Assessment Alertness/Sedation (MOAA/S) scale
|
From premedication to the recovery of patient from sedation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
1)Intraoperative hemodynamic changes
2)Requirement of additional dose of ketamine
3)Incidence of side effects such as apnoea, desaturation, PONV, post operative delirium etc.,
4)Post-operative recovery time
|
From premedication to the recovery of patient from sedation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this randomized controlled trial study is to compare the effect of Ketamine -dexmedetomidine and ketamine-fentanyl combination as an IV sedation on analgesia, quality of intraoperative sedation, homodynamic changes and recovery characteristics in children undergoing infraumbilical surgeries under spinal anaesthesia.
|